FDA applicant

Orthotone Corp.

New York, NY1 decision1988–19880 recalls

FDA records 1 decision for Orthotone Corp. (New York, NY) in 1988: 1 510(k) clearance. All are in product code HLL (Monitor, Eye Movement). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Orthotone Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Orthotone Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Orthotone Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Orthotone Corp.

Which product codes does it file in?

What has FDA decided for it lately?